23 Dec
Associate, Clinical Research
California, Sanfernando , 91340 Sanfernando USA

Vacancy expired!


  • Write informed consents and edit them for sites and check for FDA requirements
  • Help negotiate the clinical trial agreement if needed with legal
  • Understand the budget and assist the budget group with negotiation if needed
  • Help prepare and write study start-up documents: slides for training sites and field clinical specialists, clinical trial project plan, Operations Manual, patient materials, writing CRFs and instructions etc.
  • Assist the site with IRB approval and renewals
  • Has performed site qualification visits
  • Site compliance deviations, data correction forms, writing corrective action plans, excellent knowledge of the regulations
  • Written adverse event narratives
  • Committee Management - assist with the DSMB activities in the collection of source for adverse events and the de-identification of source, understanding if you have the correct source per the adverse event
  • Site initiation visits and training
  • Bachelor degree
  • +5 of experience with European Medical Device Regulations and product recertification/remediation.
Volt is an equal opportunity employer.

Vacancy expired!

Related jobs

Report job